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Scientists Report that T 4 May Have Important Role in Multiple Myeloma

^{Published on 2008-12-08 07:42:09 - Market Wire}
 

BETHESDA, Md.--([ BUSINESS WIRE ])--REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) announced today that a team of European scientists reported that in a group of 171 previously-treated multiple myeloma patients (cancer of the bone marrow), the patient group whose cancer cells had the highest levels of Tβ4 had a greater chance of not having recurrences of the disease and longer overall survival than a group of patients in the study with the lowest levels of Tβ4.

In addition, the researchers found higher levels of Tβ4 in control (non-myeloma) cells than in the patients' myeloma cells. Similar results were seen in normal murine (mouse) cells compared to a murine myeloma cell line.

It was also reported that if Tβ4 is genetically manipulated to be over-expressed in murine myeloma cells, the research team observed, "a significantly decreased proliferative capacity and an increased sensitivity to different anti-myeloma agents compared to control myeloma cells." Most importantly, the team found that when Tβ4 over-expressing murine multiple myeloma cells were injected into mice, there was a significant decrease in tumor formation and prolonged survival compared to mice injected with myeloma cells that did not over-express Tβ4.

"These impressive, ground-breaking results suggest that the gene for Tβ4 may serve as a tumor suppressor gene in patients with multiple myeloma. We look forward to future studies to further define the role Tβ4 may have in this disease," commented Dr. Allan Goldstein, Professor and Chairman of Biochemistry and Molecular Biology at The George Washington University Medical Center and RegeneRx's Chief Scientific Advisor and Board Chairman.

The study was presented at the American Society of Hematology annual meeting on Saturday, December 6, 2008 in San Francisco, CA. The research team consisted of scientists from the Vrije Universiteit Brussel, Brussels, Belgium; GMMG; University of Heidelberg, Heidelberg, Germany; and INSERM U847, Montpellier, France. The research was not conducted by or on behalf of RegeneRx.

Multiple Myeloma

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a progressive hematologic (blood) disease. It is a cancer of the [ plasma cell ], an important part of the immune system that produces [ immunoglobulins (antibodies) ] to help fight infection and disease. Multiple myeloma is characterized by excessive numbers of abnormal plasma cells in the bone marrow and overproduction of intact monoclonal immunoglobulin (IgG, IgA, IgD, or IgE) or Bence-Jones protein. Hypercalcemia, anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulin are common clinical manifestations of multiple myeloma. It is often also characterized by diffuse osteoporosis, usually in the pelvis, spine, ribs, and skull. Multiple myeloma is an incurable but treatable disease. The estimated frequency of multiple myeloma is 5 to 7 new cases per 100,000 persons per year. Accordingly, in the United States, 19,920 new cases are expected to be diagnosed in 2008. There were more than 56,000 Americans living with multiple myeloma in 2005, the most current date these statistics are available. (From the Multiple Myeloma Research Foundation, [ www.multiplemyeloma.org ].)

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. The Company is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on Tβ4, a synthetic copy of a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides and is currently sponsoring three Phase II chronic dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications.

RegeneRx Technology Background

Tβ4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. RegeneRx has identified several molecular variations of Tβ4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions throughout the U.S., have published numerous scientific articles indicating Tβ4's in vitro and invivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Abstracts of scientific papers related to Tβ4's mechanisms of action may be viewed at RegeneRx's web page: [ www.regenerx.com ].

Forward-Looking Statements

This press release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Examples of such forward-looking statements include statements concerning Tβ4's impact or potential impact on the treatment of multiple myeloma, including any impact or potential impact on tumor formation, the recurrence of the disease or its proliferative capacity, the survival time of patients with the disease, and patients' sensitivity to anti-myeloma agents, the potential diagnostic value of Tβ4, the conduct of, and results of, future studies involving Tβ4 and multiple myeloma, and the therapeutic potential of Tβ4 for dermal, ophthalmic and cardiovascular wounds, pulmonary indications, or cancer, or its use in other pharmaceutical or consumer products. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that the company's product candidates may not demonstrate safety and/or efficacy in its ongoing or future clinical trials and other development efforts, including its trials and/or other development efforts related to RGN-137, RGN-259, RGN-352 and RGN-457, the risk that the Company or its collaborators will not obtain approval to market the Company's product candidates in the U.S. or abroad, the risks associated with the Company's need for additional financing to meet capital requirements necessary for the further development and commercialization activities relating to the Company's product candidates, the risks associated with protecting the Company's intellectual property, or that the Company will not be able to obtain patent protection, or that its issued patents will be infringed, and such other risks described in the Company's quarterly report on Form 10-Q for the period ended September 30, 2008, and other filings the Company makes with the SEC. Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.